Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only basic information given.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: Male
Clinical history:
- Other: No known diseases
Controls:
None
Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: patch test (epicutaneous test)

Pre-Testing.
The test material was pre-tested on five subjects in order to determine whether sodium lauryl sulfate pre-treatment was required. A patch with the test material was applied to normal sites on the backs for 48 hours under occlusion. No subject had any irritation from these materials and it was decided to use SLS pre-treatment in the test.

Maximisation Test:
The test material was applied under occlusion to the same sites on the volar forearms of 25 healthy male volunteers for 5 alternate-day 48-hour periods. The patch sites were pre-tested for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. Following a ten-day rest period challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour application of 10 % aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.

Results and discussion

Results of examinations:
In a human maximization test the sensitising potential of the test material was determined. No sensitisation was found.

Applicant's summary and conclusion

Conclusions:
In a human maximization test the sensitising potential of the test material was determined. No sensitisation was found.
Executive summary:

In a human maximisation study, the test material was applied under occlusion to the volar forearm of 25 healthy male subjects for five alternate-day 48 -hour periods. The patch sites were pre-treated for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. Following a ten-day rest period challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour application of 10 % aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter. No sensitisation was found after 48 and 72 hours.